Non-invasive Treatment for Long COVID (Post COVID-19 Condition) Brain Fog
NCT ID: NCT06614309
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2024-09-24
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Placebo Group
Study group will complete 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air (60 minutes) for every visit during the 14 days intervention period. Subjects will then return within 7 days of their final training visit to repeat baseline testing
Training: Placebo Control
Intervention will consist of 6 to 10 study visits (3-5 sessions/week) to be completed within 14 days. Subjects will complete 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air (60 minutes) for every visit during the 14 days.
Training Group
Training Study group will be complete 6 cycles of either progressive CO2 ramp protocol or the intermittent hypoxia protocol for 60 minutes for every visit during the 14 days. Subjects will then return within 7 days of their final training visit to repeat baseline testing
Training: Progressive Carbon Dioxide Ramping
Intervention will consist of 6 to 10 study visits (3-5 sessions/week) to be completed within 14 days. Subjects will will be given the progressive CO2 ramp protocol of 60-minute sessions, which will include 6 cycles of progressive CO2 ramping starting at 0% and progressing up to 10% within 5 minutes immediately followed with 5 minutes of room air breathing in between cycles, for every visit during the 14 days.
Training: Intermittent Hypoxic Exposure
Intervention will consist of 6 to 10 study visits (3-5 sessions/week) to be completed within 14 days. Subjects will will be given the intermittent hypoxia exposure protocol of 60-minute sessions, which will include 6 cycles breathing 8-12% oxygen (O2) for 5 minutes with a target pulse oximeter saturation of 86-90%, followed by 5 minutes of breathing room air for every visit during the 14 days.
Acute exposure: Placebo, Progressive Carbon Dioxide, Intermittent Hypoxia
Study group will receive the three interventions in this order: Placebo, Progressive Carbon Dioxide, then Intermittent Hypoxia
Acute Placebo Visit
The placebo visit will include 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air.
Acute Progressive Carbon Dioxide
The progressive carbon dioxide visit will include a 60-minute progressive ramp which includes 6 cycles of progressive CO2 ramping starting at 0% and progressing up to 10% within 5 minutes immediately followed with 5 minutes of room air breathing in between cycles.
Acute Intermittent Hypoxia
The intermittent hypoxia exposure visit will include 6 cycles breathing 8-12% oxygen (O2) for 5 minutes with a target pulse oximeter saturation of 86-90%, followed by 5 minutes of breathing room air.
Acute exposure: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide
Study group will receive the three interventions in this order: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide
Acute Placebo Visit
The placebo visit will include 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air.
Acute Progressive Carbon Dioxide
The progressive carbon dioxide visit will include a 60-minute progressive ramp which includes 6 cycles of progressive CO2 ramping starting at 0% and progressing up to 10% within 5 minutes immediately followed with 5 minutes of room air breathing in between cycles.
Acute Intermittent Hypoxia
The intermittent hypoxia exposure visit will include 6 cycles breathing 8-12% oxygen (O2) for 5 minutes with a target pulse oximeter saturation of 86-90%, followed by 5 minutes of breathing room air.
Acute exposure: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide
Study group will receive the three interventions in this order: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide
Acute Placebo Visit
The placebo visit will include 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air.
Acute Progressive Carbon Dioxide
The progressive carbon dioxide visit will include a 60-minute progressive ramp which includes 6 cycles of progressive CO2 ramping starting at 0% and progressing up to 10% within 5 minutes immediately followed with 5 minutes of room air breathing in between cycles.
Acute Intermittent Hypoxia
The intermittent hypoxia exposure visit will include 6 cycles breathing 8-12% oxygen (O2) for 5 minutes with a target pulse oximeter saturation of 86-90%, followed by 5 minutes of breathing room air.
Acute exposure: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo
Study group will receive the three interventions in this order: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo
Acute Placebo Visit
The placebo visit will include 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air.
Acute Progressive Carbon Dioxide
The progressive carbon dioxide visit will include a 60-minute progressive ramp which includes 6 cycles of progressive CO2 ramping starting at 0% and progressing up to 10% within 5 minutes immediately followed with 5 minutes of room air breathing in between cycles.
Acute Intermittent Hypoxia
The intermittent hypoxia exposure visit will include 6 cycles breathing 8-12% oxygen (O2) for 5 minutes with a target pulse oximeter saturation of 86-90%, followed by 5 minutes of breathing room air.
Acute exposure: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia
Study group will receive the three interventions in this order: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia
Acute Placebo Visit
The placebo visit will include 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air.
Acute Progressive Carbon Dioxide
The progressive carbon dioxide visit will include a 60-minute progressive ramp which includes 6 cycles of progressive CO2 ramping starting at 0% and progressing up to 10% within 5 minutes immediately followed with 5 minutes of room air breathing in between cycles.
Acute Intermittent Hypoxia
The intermittent hypoxia exposure visit will include 6 cycles breathing 8-12% oxygen (O2) for 5 minutes with a target pulse oximeter saturation of 86-90%, followed by 5 minutes of breathing room air.
Acute exposure: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo
Study group will receive the three interventions in this order: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo
Acute Placebo Visit
The placebo visit will include 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air.
Acute Progressive Carbon Dioxide
The progressive carbon dioxide visit will include a 60-minute progressive ramp which includes 6 cycles of progressive CO2 ramping starting at 0% and progressing up to 10% within 5 minutes immediately followed with 5 minutes of room air breathing in between cycles.
Acute Intermittent Hypoxia
The intermittent hypoxia exposure visit will include 6 cycles breathing 8-12% oxygen (O2) for 5 minutes with a target pulse oximeter saturation of 86-90%, followed by 5 minutes of breathing room air.
Interventions
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Acute Placebo Visit
The placebo visit will include 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air.
Acute Progressive Carbon Dioxide
The progressive carbon dioxide visit will include a 60-minute progressive ramp which includes 6 cycles of progressive CO2 ramping starting at 0% and progressing up to 10% within 5 minutes immediately followed with 5 minutes of room air breathing in between cycles.
Acute Intermittent Hypoxia
The intermittent hypoxia exposure visit will include 6 cycles breathing 8-12% oxygen (O2) for 5 minutes with a target pulse oximeter saturation of 86-90%, followed by 5 minutes of breathing room air.
Training: Progressive Carbon Dioxide Ramping
Intervention will consist of 6 to 10 study visits (3-5 sessions/week) to be completed within 14 days. Subjects will will be given the progressive CO2 ramp protocol of 60-minute sessions, which will include 6 cycles of progressive CO2 ramping starting at 0% and progressing up to 10% within 5 minutes immediately followed with 5 minutes of room air breathing in between cycles, for every visit during the 14 days.
Training: Intermittent Hypoxic Exposure
Intervention will consist of 6 to 10 study visits (3-5 sessions/week) to be completed within 14 days. Subjects will will be given the intermittent hypoxia exposure protocol of 60-minute sessions, which will include 6 cycles breathing 8-12% oxygen (O2) for 5 minutes with a target pulse oximeter saturation of 86-90%, followed by 5 minutes of breathing room air for every visit during the 14 days.
Training: Placebo Control
Intervention will consist of 6 to 10 study visits (3-5 sessions/week) to be completed within 14 days. Subjects will complete 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air (60 minutes) for every visit during the 14 days.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Long COVID
Exclusion Criteria
* Coronary artery dissection or aortic dissection
* Neurological disease (e.g. dementia, Alzheimer's disease, or other brain-related disease)
* Cerebrovascular disease or stroke
* Aneurysm
* If currently has:
* Moderate-severe chronic obstructive pulmonary disease
* Uncontrolled moderate-severe asthma
* Moderate-severe bronchiectasis
* Moderate-severe interstitial lung disease, requiring the use of supplemental oxygen
* A necessity to use supplemental oxygen, for any reason
* New or worsening symptoms (decompensation) of heart failure
* Right heart disease due to chronic pulmonary disease/sleep apnea
* Uncontrolled myocardial ischemia or angina
* Uncontrolled heart arrhythmias
* Heart or lung infection (e.g. myocarditis or pericarditis)
* Left main coronary artery stenosis
* Moderate-severe aortic stenosis
* Pulmonary embolism, pulmonary infarction, or other blood clots
* Severe respiratory disease
* Chronic kidney disease
* Chronic liver disease
* Females of childbearing potential will complete a urine pregnancy test at their baseline visit to rule out pregnancy
* BMI \>40
* Study staff unable to obtain adequate signal for cerebral blood flow
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Courtney M. Wheatley
Principal Investigator
Principal Investigators
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Courtney Wheatley-Guy
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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Jordan Parks
Role: primary
Other Identifiers
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24-006115
Identifier Type: -
Identifier Source: org_study_id